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临床试验/NCT05402202
NCT05402202已完成不适用

Clinical Performance and Accuracy of Healing Abutment With Scan Peg for Single Posterior Implant-supported Restorations

Alexandria University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Quality of proximal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body

研究概览

简要总结

The aim of this randomized clinical trial is to evaluate the clinical performance through prosthodontic, periodontal and radiographic evaluation of single screw-retained implant-supported restorations fabricated by intraoral scanning of healing abutment with scan peg in comparison to scan body

详细描述

Evaluation of the clinical performance through prosthodontic, periodontal and radiographic evaluation of single screw-retained implant-supported restorations fabricated by intraoral scanning of healing abutment with scan peg in comparison to scan body

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients who are classified as ASA I or II physical status and require mandibular single implants (single missing mandibular posterior teeth) with:
  • Adequate interarch and mesiodistal space.
  • Proper bone height and width.
  • Adequate zone of keratinized tissue (at least 2 mm)

排除标准

  • Any systematic disease as uncontrolled diabetes mellitus or metabolic bone diseases
  • A history of head and neck radiation treatment.
  • Periodontal diseases.
  • Poor oral hygiene (Silness-Löe plaque index score 2 and 3) (32)
  • Parafunctional habits.
  • Malocclusion.

结局指标

主要结局

Quality of proximal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body

时间窗: Through study completion, an average of 1 year

The proximal contacts will be evaluated with dental floss 1. Open: an open contact will be reported if there is no resistance against floss 2. Ideal: an ideal contact will be reported if there is some resistance to interproximal floss insertion. 3. Tight: a tight contact will be reported if it prevents the passage of floss through the proximal contact point. The percentage of proximal contacts will be calculated for each group at day of crown delivery, 3 months and 6 months later.

Scanning time (healing abutment-scan peg vs scan body)

时间窗: Through study completion, an average of 1 year

The scanning time by intraoral scanner will be recorded in both groups

Evaluation of occlusion by digital occlusal analyzer

时间窗: Through study completion, an average of 1 year

occlusal force of implant-supported restorations will be measured

Quality of occlusal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body

时间窗: Through study completion, an average of 1 year

An evaluation of occlusion will be executed with 2 layers of shim stock of 12µ. 1. No adjustment: if the shimstock is held when the patient clenches and does not need any adjustment. 2. Mild adjustment: If the shim stock is held after simple closure, the occlusal contact will be reported as heavy and received mild chairside adjustment. 3. Major adjustment: If the crown is returned to the manufacturing technician, the adjustment is considered major. 4. Out of occlusion: If the shim stock passes without resistance after clenching, an open contact will be reported. The percentage of occlusal contacts will be calculated for each group at day of crown delivery, 3 months and 6 months later.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rania Elsayed

Assistant Lecturer, Department of Prosthodontics, Faculty of Dentistry

Alexandria University

研究点 (2)

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